RU-486: Killer Pills

Most people assume that advances made in medicine and science are helpfuland save lives. Regrettably, that is not always true. In the case of the abortion pill, RU-486, women are not helpedand lives are certainly not saved. Yet in September of 2000, the Food and Drug Administration (FDA) approved RU-486, or Mifeprex, for sale in the United Statesa drug whose only purpose is to kill human beings.

POLITICS AND CONTROVERSYThere are reasons this chemical abortion is controversial. In 1993, President Bill Clinton overturned the ban on RU-486. He ordered the U.S. Department of Health and Human Services (HHS) to review ways to test, license, and manufacture the drug. HHS Secretary Donna Shalala compelled Roussel-Uclaf, the French manufacturer of RU-486, to hand the patent overfor freeto the Population Council, a pro-abortion group. The Population Council used intense political pressure on the FDA to approve the drug without the necessary testing or restrictions to ensure patients safety.

The Population Council created Danco Laboratories to market and distribute RU-486. Danco could not find a company in the United States willing to manufacture the drug, due to the risk that healthy women would be injured or have children born with abnormalities. So it contracted with a company in China, which was previously cited by the FDA for tainted drugs.

HOW RU-486 WORKSIn their campaign to promote RU-486, pro-abortion activists claimed that RU-486 makes abortion easier, safer and more private. But there is nothing easy or safe about RU-486.

The FDA limits RU-486 to women in the first seven weeks of pregnancy. After taking three tablets in the abortion facility or doctors office, the woman goes home. This drug blocks progesterone from getting to the developing baby. Without this nutrient hormone, the baby starves to death.

Thirty-six to 48 hours later, the woman returns to the doctor to take a second drug, misoprostol, to expel the baby. Misoprostol is an ulcer drug that the manufacturer, Searle, has warned doctors should not be used in pregnancy-related conditions. It is at this time that the woman is most likely to suffer complications.

Seven days later, she returns for an exam to make sure the baby has been expelled and to monitor her bleeding. If the procedure failed, the woman then undergoes a surgical abortion.

The procedure requires three clinical visits and access to emergency medical facilities in the event of complications.

SIDE EFFECTSWomen who take RU-486 experience firsthand just how difficult it is. Common side effects include painful contractions, nausea, vomiting, diarrhea, pelvic pain and spasms, dizziness and headachesas well as the trauma of potentially seeing their aborted baby. Some women have been hospitalized and required surgery and/or a blood transfusion. In most cases, women endured prolonged bleeding, anywhere from nine to 30 days.

It is not known what the potential long-term side effects might be on a womans fertility, future pregnancies or immune system.

Since its approval, one woman died from a ruptured ectopic pregnancy. Two 15-year old girls suffered life-threatening infections. One 21-year-old had a heart attack. A woman in Canada died during the trials from bacterial infection, which caused the trials to be suspended. These were healthy women, who, after taking RU-486, ended up very unhealthy.

Edouard Sakiz, former president of Roussel-Uclaf, described RU-486 as not at all easy to use. He explained, The woman must live with this for a full week; this is an appalling psychological ordeal.

ABORTION BEFORE SAFETYIn June of 2000, the FDA notified the Population Council of the various restrictions under which RU-486 would be approvedall intended to ensure the safety of the patient. These restrictions reflected the limitations used in the trials and how it is used in Europe. For example, ultrasound must be used to determine the age and place of pregnancy, since the complication rate for RU-486 increases dramatically if used after 7 weeks, and it does nothing to treat an ectopic pregnancy, which has the same symptoms as common RU-486 side effectspain and bleeding.

The Population Council leaked the list of restrictions to pro-abortion groups and the media. The groups complained publicly and to the FDA that the restrictions would limit the accessibility of the drug. Newspapers ran editorials criticizing the FDA. The FDA buckled and dropped nearly all the guidelines intended to protect patients.

The remaining restrictions were weakened. For example, no longer could only physicians trained in dating pregnancies, managing complications or performing surgical abortions as a backup be allowed to administer RU-486. Instead, FDA allows RU-486 to be provided by or under the supervision of a physician. No qualifications were established as to who can work under the supervision of a physician.

ILLEGAL APPROVALConcerned Women for America, along with the American Association of Pro-Life Obstetricians and Gynecologists and the Christian Medical Association, filed a Citizen Petition with the FDA on August 20, 2002. This legal document outlines the numerous violations the FDA committed in its approval of RU-486 and how these violations resulted in the injury and death of women.

RU-486 was approved under a special restricted distribution approval process known as Subpart H, reserved only for drugs that treat severe or life-threatening illnesses. Even the Population Council complained that approval under this provision was unlawful, unnecessary and undesirable. Pregnancy is not a severe or life-threatening illness. Other drugs approved under Subpart H treat fatal diseases, such as cancer or AIDS, and can have serious side effects considered acceptable when the alternative is death. However, Subpart H allows the FDA to retain the right to oversee the drugs use after approval, and the right to pull the drug if it proves too dangerous or the manufacturer allows the drug to be used improperly. The clinical trials to test the safety and efficacy of RU-486 were seriously defective. Neither the French nor the U.S. trials met FDAs standards. The data from the French trials suggest fraud, evidence tampering and under-reporting of complications. No data from the U.S. or French trials were obtained from blind testing, from randomized tests or from comparisons with control groupsFDA requirements to ensure unbiased trials. Yet even these biased trials are not reassuring about the safety or efficacy of this drug: 99 percent of the U.S. test subjects suffered some adverse event, and 23 percent of those were considered serious. Abortion was complete in only 92 percent of the test cases. Nearly all the safety precautions the FDA recommended to protect women from being injured or killed by RU-486 were dropped from the final approval. These precautions included ultrasound diagnosis to verify the age and location of the pregnancy, and that the prescribing physician be able to treat an incomplete abortion and to have admitting privileges at a nearby hospital. These are all lower safety standards than required in other countries where RU-486 is used. FDA ordered that a second drug, misoprostol, be used in conjunction with RU-486, since RU-486 is not effective in completing an abortion alone. However, misoprostol is an ulcer medication and its manufacturer, Searle Laboratories, warned doctors it does not want it used for abortion. The FDA has, in effect, mandated an unapproved off-label use of a drug, an action that is utterly without precedent or legal authority. The FDA waived the pediatric rule with no explanation. Any drug given to adolescents must be tested on adolescents. Teenagers bodies go through rapid hormonal maturation; their bodies are different from adults. No one under 18 (or over 35) was allowed to participate in the RU-486 clinical trials. Other countries have the same age restrictions. Yet the FDA did not limit the age of females to whom RU-486 could be given. Such prominent liberals as Sen. Hillary Rodham Clinton (D-New York) and Rep. Henry Waxman (D-California) have avidly championed the enforcement of the pediatric rule because they fear that pharmaceutical companies might endanger the health of children by cutting corners in the clinical trials. Complications reported to the FDA demonstrate that RU-486 is a serious threat to the health and safety of women. These include two fatalities and 20 other near-fatal complications including a heart attack, two cases of systemic bacterial infection in 15-year olds and several hospitalizations for hemorrhaging. The FDA and Danco sent a letter to physicians in April 2002 warning of the complications reported since the FDA approved RU-486. This alone would cause an ordinary drug to be removed from the market immediately. Danco, the distributor of RU-486, has a legal obligation to ensure that the drug be administered only in accord with the procedures approved by the FDA. Yet there are abortion providers who are advertising that they will administer RU-486 up to nine weeks of gestation (instead of the seven-week limit set by the FDA) and who have patients self-administer misoprostol, the second drug, at home. It is obvious that Danco is failing to live up to its post-approval obligations.

The Citizen Petition and related documents can be found at www.cwfa.org.

WOMEN AT RISKAbortion is a difficult, traumatizing procedure that has ended the lives of millions of children and scarred the women who endured it. Chemical abortions like RU-486 will not advance womens health. They will only advance our national tragedy of abortion.

The FDA violated its own safety regulations when it approved RU-486 and put womens lives and health at risk. To protect further women from being harmed, it must pull its approval for Mifeprex.

Wendy Wright is senior policy director for Concerned Women for America. Michael Schwartz and Marian Wallace contributed to the writing of this paper.